Job Description
Job Description$55.00-69.00/hour
Contract Position
As a Regulatory Affairs Specialist Consultant, you will be responsible for:
- Formulate and execute activities associated with regulatory submissions of a novel robotic medical device in the US market as well as markets outside of the US (e.g. Europe, Asia).
- In collaboration with subject matter experts, independently prepare and author regulatory documents such as Design Dossiers, Technical Files, Device License Applications, Investigational Device Exemptions (IDE), and pre-market notifications, such as De Novo.
- Support and manage interactions with regulatory bodies (e.g., FDA, Notified Body)
- Support Clinical Affairs (Research) in Clinical Evaluation Reports, Post Market Surveillance Reports as needed. Lead the reporting of these technical documents to regulatory bodies as required by internal quality procedures.
- Participate and support new product development teams by defining regulatory requirements for product development along with ensuring adherence to internal Design Control SOPs;
- Support clinical affairs and clinical operations as needed (i.e., periodic reporting of safety to regulatory agencies)
- Support document change control activities that require regulatory approval.
- Review validation protocols and reports to support regulatory submissions.
- Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the discipline as relevant to assigned projects.
- Ensure compliance with regulatory agencies and all applicable standards worldwide for legacy and new products.
- Work on complex challenges that require in depth knowledge of regulatory principles and practices.
- Other duties as assigned.
Required skills to have for the success of this role:
- Bachelor’s Degree in a scientific discipline required, Master’s Degree or higher preferred.
- Minimum of 15+ years’ experience in strategic Clinical and Regulatory Affairs tactical executions (including authoring regulatory submissions and demonstrating favorable outcomes such as regulatory approvals) a must.
- Proficiency in ISO 13485, 21CFR820 (including Design Controls and Risk Analysis), EU MDR Regulation (EU) 2017/745 is a must.
- Experience in medium to high-risk devices with, along with De Novo or PMA applications, and demonstrated approvals are a must.
- Experience in generating, updating and managing Clinical Evaluation Plans/ Reports and Post Market Surveillance Plans/Reports is a must.
- Experience with authoring and managing Technical Files and Design Dossiers conforming with Europe’s Medical Device Regulation is a must.
- Proficiency and experience in rest of world regulatory submissions requirements for premarket approvals or clinical trial authorizations (e.g., Asia, South America) are ideal.
- Experience in project management and associated project management tools (e.g., Microsoft Project) is a must.
- Knowledge and experience in clinical affairs including IDE submissions are ideal.
- Experience with complex electromechanical, software controlled robotic systems, AI, SaMD, neuro devices is ideal.
- Experience with FDA inspection (QSIT) and Notified Body audits is required.
- Experience with FDA BIMO inspection is ideal.
- RAC-devices certificate preferred.
- Ability and willingness to work in a lean, fast-paced environment.
- Willing to travel up to 5%.